Novasure® Instructions for Use and Controller Operator's Manual

ENGLISH NovaSure® Instructions for Use and Controller CAUTION: FEDERAL (USA) LAW RESTRICTS THIS DEVICE TO Operator’s Manual SALE BY OR ON THE ORDER OF A PHYSICIAN TRAINED IN THE USE OF THE DEVICE. Table of Contents Read all instructions, cautions and warnings prior to use. Failure to follow any instructions or to heed any warnings or precautions Physician Checklist...... 1 could result in serious patient injury. System Description...... 1 NOTE: The manual that accompanied the disposable device may Indications...... 3 contain a more recent revision of the NovaSure system instructions Contraindications ...... 3 than the manual provided with the controller. The NovaSure disposable device is not to be used with other Warnings...... 3 controllers and/or RF generators, and the NovaSure RF controller is Precautions...... 4 not to be used with other disposable devices. Adverse Events ...... 5 The NovaSure disposable device does not contain latex. Anticipated Post-Procedural Complications ...... 6 Physician Checklist Other Adverse Events ...... 6 The physician must: Clinical Study...... 6 • have sufficient experience in performing procedures within the uterine Patient Selection...... 9 cavity, such as IUD insertion or dilation and curettage (D&C) and with adequate training, knowledge and familiarity using the NovaSure Patient Counseling...... 9 system; Pretreatment Preparation of Patient...... 9 • review and be familiar with the instructions and complete either NovaSure Impedance Controlled Endometrial Ablation System NovaSure training or be trained by a qualified physician; Instructions for Use...... 10 • be aware of the appropriate sequence of actions detailed in the Periodic Maintenance and Service: Instructions for Use and Troubleshooting sections of this manual to Model 08-09 RF Controller ...... 16 abort, resolve and/or continue the treatment in the event the system detects a loss of CO during the cavity integrity assessment (CIA), NovaSure Model 08-09 RF Controller LED Descriptions. . . 18 2 which indicates a possible uterine perforation. Troubleshooting Most Common Alarms: Adjunct personnel must be familiar with these instructions and other Model 08-09 RF Controller ...... 18 training materials prior to using the NovaSure system. Periodic Maintenance and Service: Model 10 RF Controller ...... 21 System Description The NovaSure impedance controlled endometrial ablation system NovaSure Model 10 RF Controller Screen Icons...... 21 consists of the NovaSure disposable device with connecting cord, Troubleshooting Most Common Alarms: NovaSure RF controller (controller), NovaSure CO2 canister, desiccant, Model 10 RF Controller...... 22 foot switch and power cord, which are designed to be used together as Additional Troubleshooting...... 24 a system. Replacement Instructions...... 24 Specifications ...... 24 Cleaning and Sanitizing ...... 28 Parts List...... 28 Warranty ...... 28 Technical Support and Product Return Information ...... 29 Symbol Definitions ...... 30

NovaSure Disposable Device with Connecting Cord, Including Suction Line Desiccant

1 ENGLISH NovaSure Disposable Device Description NovaSure Model 08-09 NovaSure Model 10 The NovaSure disposable device consists of a single-patient use, RF Controllers RF Controller conformable bipolar electrode array mounted on an expandable frame that can create a confluent lesion on the entire interior surface area of the uterine cavity. The disposable device is inserted transcervically into the uterine cavity, and the sheath is retracted to allow the bipolar electrode array to be deployed and conform to the uterine cavity. The bipolar electrode array is formed from a metalized, porous fabric through which steam and moisture are continuously suctioned from the desiccated tissue. The disposable device works in conjunction with a dedicated NovaSure RF controller to perform customized, global endometrial ablation in an average of approximately 90 seconds without the need for concomitant hysteroscopic visualization or endometrial pretreatment. The specific configuration of the bipolar electrode array and the predetermined power of the controller create a controlled depth of ablation in uteri sounding less than or equal to 10 cm and having a minimum cornu-to-cornu distance of 2.5 cm. During the ablation process, the flow of radio frequency (RF) energy NovaSure RF Controller Description vaporizes and/or coagulates the endometrium regardless of its The NovaSure RF controller is a constant power output generator with a thickness and desiccates and coagulates the underlying, superficial nominal maximum power delivery capability of 180 watts. The controller myometrium. automatically calculates the power output based on the uterine cavity The controller automatically calculates the optimal power level (W) length (sound measurement minus the length of the endocervical canal) required for the treatment of the uterine cavity, based on uterine and width measurements that the user key-enters into the controller. size. As tissue destruction reaches an optimal depth, increasing Monitoring tissue impedance during the ablation process automatically tissue impedance causes the controller to automatically terminate controls the depth of endo-myometrial ablation. The NovaSure procedure power delivery, thereby providing a self-regulating process. Blood, self-terminates once endometrial vaporization and superficial myometrial saline and other liquid present in the uterine cavity at the time desiccation have reached 50 ohms of impedance at the tissue-electrode of the procedure, as well as vapor liberated from the desiccated interface, or when the treatment timer reaches two minutes. Integral tissue, are evacuated by continuous, automatic suctioning. to the controller is the cavity integrity assessment system (CIA) which is designed to determine whether there is a defect or perforation in the The disposable device is connected to the controller via a cord wall of the uterus. After the disposable device is placed into the uterine containing the RF cable, suction tubing used for pressure monitoring cavity, CO2 is delivered through the central lumen of the disposable during the cavity integrity assessment cycle and for suction during device into the cavity, via the vacuum feedback tubing, at a safe flow the ablation cycle, and vacuum feedback tubing used for carbon rate and pressure. If the CO2 pressure in the cavity is maintained for a dioxide delivery during the cavity integrity assessment cycle and short period of time, indicating that the uterine cavity is intact, then the vacuum monitoring during the ablation cycle. The disposable device CIA will allow the NovaSure RF controller to be enabled and proceed with has been sterillized with ethylene oxide (EO). the treatment phase. A vacuum pump contained within the NovaSure RF controller creates and maintains a vacuum in the uterine cavity throughout the endometrial ablation procedure. Once the vacuum is stabilized, the vacuum level is monitored throughout the remainder of the ablation process.

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NovaSure Suction Line Desiccant • a patient who is pregnant or who wants to become pregnant in the Description future. Pregnancies following ablation can be dangerous for both The NovaSure suction line desiccant mother and fetus. is a non-sterile, single-patient use • a patient with known or suspected endometrial carcinoma (uterine component that the user attaches cancer) or pre-malignant conditions of the endometrium, such as in-line with the suction tubing, prior unresolved adenomatous hyperplasia. to connecting the disposable device • a patient with any anatomic condition (e.g., history of previous to the NovaSure RF controller. The classical cesarean section or transmural myomectomy) or pathologic desiccant absorbs the moisture condition (e.g., long-term medical therapy) that could lead to removed from the uterine cavity via weakening of the myometrium. the suction tubing during the ablation • a patient with active genital or urinary tract infection at the time of procedure. the procedure (e.g., cervicitis, vaginitis, endometritis, salpingitis or NovaSure Foot Switch cystitis). Description • a patient with an intrauterine device (IUD) currently in place. The NovaSure foot switch is a Presence of an IUD in the uterine cavity can interfere with a NovaSure pneumatic switch that connects to the procedure. NovaSure RF controller front panel. It • a patient with a uterine cavity length less than 4 cm. The minimum is used to activate the NovaSure RF length of the electrode array is 4 cm. Treatment of a uterine cavity with controller and does not contain any a length less than 4 cm will result in thermal injury to the endocervical electrical components. canal. • a patient with a uterine cavity width less than 2.5 cm, as determined by the WIDTH dial of the disposable device following device NovaSure CO Canister 2 deployment. Description • a patient with active pelvic inflammatory disease. The NovaSure CO2 canister is a 16-

gram CO2 (USP) canister. It is attached WARNINGS to the regulator located on the back FAILURE TO FOLLOW ANY INSTRUCTIONS OR FAILURE TO HEED panel of the NovaSure RF controller ANY WARNINGS OR CAUTIONS COULD RESULT IN SERIOUS PATIENT prior to applying line voltage to INJURY. the NovaSure RF controller. The THE NOVASURE DISPOSABLE DEVICE MUST BE USED ONLY IN CO2 is used by the cavity integrity assessment system to pressurize the CONJUNCTION WITH THE NOVASURE RF CONTROLLER. uterine cavity. THE NOVASURE PROCEDURE IS INTENDED TO BE PERFORMED ONLY NovaSure AC Power Cord ONCE DURING A SINGLE OPERATIVE VISIT. THERMAL INJURY TO THE Description BOWEL MAY OCCUR WHEN MULTIPLE NOVASURE THERAPY CYCLES The NovaSure AC power cord, ARE PERFORMED DURING THE SAME OPERATIVE VISIT. a medical grade cord, connects Uterine Perforation the NovaSure RF controller to • Use caution not to perforate the uterine wall when sounding, dilating the appropriate line voltage. The or inserting the disposable device. receptacle for the power cord, the • If the disposable device is difficult to insert into the cervical canal, power input module, is located on use clinical judgment to determine whether or not further dilation is the back panel of the NovaSure RF required. controller. • The NovaSure system performs a cavity integrity assessment (CIA) INDICATIONS to evaluate the integrity of the uterine cavity and sounds an alarm The NovaSure system is intended to ablate the endometrial lining of the warning of a possible perforation prior to treatment (Step 2.36). uterus in pre-menopausal women with menorrhagia (excessive bleeding) (Although designed to detect a perforation of the uterine wall, it is due to benign causes for whom childbearing is complete. an indicator only and it might not detect all perforations under all possible circumstances. Clinical judgment must always be used.) CONTRAINDICATIONS • If a uterine perforation is suspected, the procedure should be The NovaSure impedance controlled endometrial ablation system is terminated immediately. contraindicated for use in:

3 ENGLISH • If the cavity integrity assessment fails after reasonable attempts operation takes approximately 10 seconds and must be performed to implement the troubleshooting procedures (step 2.36), abort with the disposable device external to the patient to eliminate the procedure. the risk of air or gas embolism. The NovaSure RF controller CAVITY • For patients in whom the procedure was aborted due to a suspected ASSESSMENT LED flashes red (Model 08-09 RFCs) or a purging device uterine wall perforation, a work-up for perforation should be screen appears (Model 10 RFC) and an audible pulsed tone sounds considered prior to discharge. throughout the purge procedure. When the tone and the LED/screen message stops it is safe to insert the disposable device. General • Endometrial ablation using the NovaSure system is not a sterilization • For patients with cardiac pacemakers or other active implants, a procedure. Therefore, the patient should be advised of appropriate possible hazard exists due to interference with the action of the birth control methods. pacemaker that may occur and may damage the pacemaker. Consult the pacemaker manufacturer for further information when use of the • Endometrial ablation does not eliminate the potential for endometrial NovaSure system is planned in patients with cardiac pacemakers. hyperplasia or adenocarcinoma of the endometrium and may mask the physician’s ability to detect or make a diagnosis of such pathology. • Care should be taken to ensure the patient does not contact metal parts which are earthed or which have an appreciable capacitance to • Endometrial ablation is intended for use only in women who do earth. not desire to bear children because the likelihood of pregnancy is significantly decreased following the procedure. Pregnancy following • Danger: explosion hazard. Do not use in the presence of a flammable ablation may be dangerous for both mother and fetus. anesthetic mixture. Do not use in the presence of flammable gases or liquids. • Patients who undergo endometrial ablation procedures who have previously undergone tubal ligation are at increased risk of developing • Failure of the NovaSure RF controller could result in an unintended post ablation tubal sterilization syndrome which can require increase in output power. hysterectomy. This can occur as late as 10 years post procedure. PRECAUTIONS • A health hazard may exist in the case where the NovaSure procedures • It has been reported in the literature that patients with a severely is performed in the presence of a thermally and electrically conductive anteverted, retroflexed or laterally displaced uterus are at greater risk metal micro-insert that is improperly positioned (e.g., perforating the of uterine wall perforation during any intrauterine manipulation. fallopian tube or the myometrium). If this occurs, heat can be drawn • A false passage can occur during any procedure in which the uterus away from the intended treatment area toward other tissue and/or is instrumented, especially in cases of severe anteverted retroflexed organs in contact with the conductive object, which may be sufficient or a laterally displaced uterus. Use caution to ensure that the device is to cause localized burns. As a result, correct placement of the metal properly positioned in the uterine cavity. micro-insert must be confirmed prior to performing the NovaSure • The NovaSure system consists of the following components: procedure. - single-patient use NovaSure disposable device with connecting cord - NovaSure RF controller Technical - NovaSure CO canister • Do not use the sterile, single-patient use disposable device if the 2 packaging appears to be damaged or there is evidence of tampering. - NovaSure desiccant • The disposable device is for single-patient use only. Do not reuse or - NovaSure foot switch re-sterilize the disposable device. The risk of reusing the disposable - power cord device includes but is not limited to the following: To ensure proper operation, never use other components with the NovaSure system. Inspect the components regularly for damage, • ineffective procedure and do not use them if damage is apparent. The use of any cables or • infection (major) accessories other than those specified in these instructions may result • electric shock in increased emissions or decreased immunity of the RF controller. • transmission of communicable disease • The RF controller must be installed and put into service according • cervical laceration to the guidance provided in these instructions to ensure its • uterine perforation electromagnetic compatibility. Refer to the electromagnetic emissions • If any hysteroscopy procedure is performed with hypotonic solution and immunity tables in the Specifications section. immediately prior to NovaSure treatment, then the uterine cavity must • The RF controller should not be used adjacent to or stacked with other be flushed with normal saline prior to treatment with the NovaSure equipment. If adjacent or stacked use is necessary, the RF controller system. The presence of hypotonic fluid may reduce the efficiency of should be observed to verify normal operation in the configuration in the NovaSure system. which it will be used. • Plugging the disposable device into the controller starts CO2 flow to purge any air out of the disposable device and tubing. This purging

4 ENGLISH • Portable and mobile RF communications equipment can affect the over-treatment). It may also result in distortion of the current in the RF controller. Refer to the electromagnetic immunity tables in the conductive object, e.g., monitors may display false readings. Specifications section for recommended separation distances. • Grounding reliability is only achieved when equipment is connected to • Patients who have undergone endometrial ablation and are later a receptacle marked “hospital grade”. placed on hormone replacement therapy should have a progestin • To avoid risk to patient and operators, do not use this equipment in included in their medication regimen in order to avoid the increased the presence of intentional magnetic sources, intentional ultrasound risk of endometrial adenocarcinoma associated with unopposed sources, or intentional heat sources. estrogen replacement therapy. • The cervical collar must be fully retracted to its proximal position in • The safety and effectiveness of the NovaSure system has not been order to minimize the potential for damage to the sheath when closing fully evaluated in patients: the array. - with a uterine sound measurement greater than 10 cm; • The plastic tubing in the NovaSure Disposable Device contains di-(2- - with submucosal fibroids that distort the uterine cavity; ethylhexyl) phthalate; DEHP. In accordance with European Commission - with bicornuate, septate or sub-septateuteri; Directive 67/548/EEC, it is noted here that DEHP may impair fertility; - with medical (e.g., GnRH agonist) or surgical pretreatment; it also may cause harm to the unborn child. The NovaSure device is - who have undergone a previous endometrial ablation including the contraindicated for use in pregnant women or women that want to NovaSure endometrial ablation procedure; or, become pregnant in the future. Pregnancies following ablation can be - who are post-menopausal. dangerous for both mother and fetus. Sound medical judgment should • Do not attempt to repair the controller if problems are suspected. be used. Call Hologic Technical Support or a Hologic sales representative for NovaSure 3-Year Clinical Data instructions. Adverse Events • Cables to the disposable device should be positioned such that contact The NovaSure system was evaluated in a randomized, prospective, with patient or other leads is avoided. multi-center clinical study of 265 patients with abnormal uterine • The user should inspect the disposable device for damage prior to use. bleeding comparing the NovaSure system to a control arm of wire loop • The suction line desiccant is non-sterile, and the packaging should not resection of the endometrium followed by rollerball ablation. be placed in the sterile field. • If the ARRAY POSITION LED light is illuminated on Models 08- Table 1A. Intra-Operative Adverse Events 09, or an Array Position message is displayed on the Model 10 NovaSure Loop Resection screen, see the Troubleshooting section under “ARRAY POSITION Plus Rollerball ALARM” Adverse Event n=175 (%) n=90 (%) • Do not use the NovaSure suction line desiccant if desiccant material is Bradycardia 1 (0.6%) 0 (0.0%) pink in color. Uterine perforation 0 (0.0% 3 (3.3%) • The disposable device must be external to (outside of) the patient before connecting the cord to the appropriate port on the front panel of Cervical tear 0 (0.0% 2 (2.2%) the controller (step 2.15). Cervical stenosis 0 (0.0% 1 (1.1%) • The carbon dioxide canister contains gas under high pressure. In the TOTAL 1 (0.6%) 6 (6.7%)

event of a breached CO2 canister or line, allow the canister to exhaust completely, and allow the canister and/or lines to equilibrate to room temperature prior to handling. Table 1B. Post-Operative Adverse Events < 24 Hours

• CO2 continuously flows from the time that the disposable device is NovaSure Loop Resection plugged into the controller until the CIA portion of the procedure is Plus Rollerball Adverse Event n=175 (%) n=90 (%) complete. To minimize the duration of CO2 flow and potential risk of embolism, perform the seating procedure immediately after inserting Pelvic pain/cramping 6 (3.4%) 4 (4.4%) the disposable device and proceed directly from the seating procedure Nausea and/or vomiting 3 (1.7%) 1 (1.1%) to the CIA. TOTAL 9 (5.1%)* 5 (5.6%)** • Electrically conductive objects (e.g., monitoring electrodes from other * Nine events reported in 6 (3.4%) patients devices) that are in direct contact with the electrode array of the ** Five events reported in 4 (4.4%) patients disposable device or in close proximity to the electrode array may draw current away from the array. This may result in localized burns to the patient or physician or in distortion of the electrical field of the array, which would change the therapeutic effect (under-treatment or

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Table 1C. Post-Operative Adverse Events > 24 Hours – 2 Weeks Other Adverse Events As with all endometrial ablation procedures, serious injury or death can occur. NovaSure Loop Resection Plus Rollerball The following adverse events could occur or have been reported in Adverse Event n=175 (%) n=90 (%) association with the use of the NovaSure system: Hematometra 1 (0.6%) 0 (0.0% • post-ablation tubal sterilization syndrome Urinary tract infection 1 (0.6%) 1 (1.1%) • pregnancy-related complications (NOTE: PREGNANCY FOLLOWING Vaginal infection 1 (0.6%) 0 (0.0% ENDOMETRIAL ABLATION IS VERY DANGEROUS FOR BOTH THE MOTHER AND THE FETUS.) Endometritis 0 (0.0% 2 (2.2%) • thermal injury to adjacent tissue Pelvic inflammatory disease 0 (0.0% 1 (1.1%) • perforation of the uterine wall Hemorrhage 0 (0.0% 1 (1.1%) • difficulty with defecation or micturition Pelvic pain/cramping 1 (0.6%) 1 (1.1%) • uterine necrosis Nausea and/or vomiting 1 (0.6%) 1 (1.1%) • air or gas embolism TOTAL 5 (2.9%)* 7 (7.8%)** • infection or sepsis * Five events reported in 4 (2.3%) patients • complications leading to serious injury or death ** Seven events reported in 6 (6.7%) patients Clinical Study Table 1D. Post-Operative Adverse Events > 2 Weeks – 1 Year Purpose: Safety and effectiveness of the use of the NovaSure system NovaSure Loop Resection was compared to wire loop resection of the endometrium followed by Plus Rollerball rollerball ablation in premenopausal women suffering from menorrhagia Adverse Event n=175(%) n=90 (%) secondary to benign causes. Hysterectomy 3 (1.7%) 2 (2.2%) Pretreatment: Patients randomized into the NovaSure arm received Hematometra 1 (0.6%) 2 (2.2%) no endometrial pretreatment (e.g., hormone, D&C or patient timing). Urinary tract infection 2 (1.1%) 2 (2.2%) Patients randomized into the control arm received wire loop resection as Vaginal infection 5 (2.9%) 2 (2.2%) an endometrial pretreatment. Endometritis 2 (1.1%) 1 (1.1%) Study endpoints: The primary effectiveness measure was a validated menstrual diary scoring system developed by Higham (Higham JM, Pelvic inflammatory disease 2 (1.1%) 0 (0.0% O’Brien PMS, Shaw RW Br J Obstet Gynaecol 1990; 97:734-9). Hemorrhage 1 (0.6%) 0 (0.0% Assessment of menstrual blood loss was performed using a pictorial Pelvic pain/cramping 5 (2.9%) 6 (6.7%) blood loss assessment chart (PBLAC). Patient success was defined as TOTAL 21 (12.0%)* 15 (16.17%)** a reduction in menstrual flow at 1 year post-procedure to a diary score * 21 events in 19 (10.9%) patients of <75. Study success was defined as a statistical difference of less ** 15 events in 15 (16.7%) patients than 20% in patient success rates between the NovaSure impedance Anticipated Post-Procedural Complications controlled endometrial ablation system and wire loop resection plus For any endometrial ablation procedure, commonly reported post- rollerball ablation. Patients were contacted at two and three years and operative events include the following: asked a series of questions regarding their bleeding over the previous 12 months. Each patient’s menstrual bleeding status was determined • Cramping/pelvic pain was reported for 3.4% of the NovaSure patients at two and three years using the one-year PBLAC score and bleeding and 4.4% of the wire resection loop plus rollerball-treated patients pattern as a reference. Thus, it was possible to directly compare a within 24 hours of the procedure. Postoperative cramping can range patient’s bleeding pattern or menstrual status at one year to the bleeding from mild to severe. This cramping will typically last a few hours and pattern at two and three years. rarely continues beyond the first day following the procedure. • Nausea and vomiting were reported for 1.7% of the NovaSure patients Secondary endpoints included anesthesia regimen, length of procedure and 1.1% of the wire loop resection plus rollerball patients within and responses from a quality-of-life questionnaire. Safety evaluation was 24 hours of the procedure. When present, nausea and vomiting based on the adverse events reported during the study. typically occur immediately following the procedure, are associated Methods: A randomized (2:1), prospective clinical study was conducted with anesthesia and can be managed with medication. at 9 clinical sites and included 265 patients diagnosed with menorrhagia. • Vaginal discharge Menstrual diary scores were collected pre-operatively and monthly for • Vaginal bleeding/spotting 12 months post-procedure. Patients were treated at any time in their menstrual cycle. None of the patients received hormonal pretreatment to thin the endometrial lining. Control patients received hysteroscopic

6 ENGLISH wire loop resection of the endometrium as a mechanical means of Table 2. Patient Accountability endometrial pretreatment followed by rollerball ablation. Study subjects were required to meet the following key patient selection criteria: Number of Patients NovaSure Wire Loop Resection Inclusion criteria Plus Rollerball • Refractory menorrhagia with no definable organic cause (dysfunctional Entered into Study 175 90 uterine bleeding) (Intent-to-Treat population) • Ages 25 to 50 years of age Aborted procedures*1 -4 -2 • Uterine sound measurement of 6.0–10.0 cm (external os to internal fundus) Treated 171 88 • Minimum PBLAC score of >150 for 3 months prior to study enrollment; Additional treatment* -4 -2 or PBLAC score >150 for one month for women who: Hysterectomy*2 -3 -2 - had at least 3 prior months (documented) failed medical therapy; Lost to follow-up* -5 -2 - had a contraindication to medical therapy; or Hodgkin’s disease* -1 0 - refused medical therapy. Pelvic Pain - administered -1 0 Exclusion criteria leuprolide* • Presence of bacteremia, sepsis or other active systemic infection 12-Month 157 82 • Active or recurrent chronic pelvic inflammatory disease follow-up data available • Patient with documented coagulopathies or on anticoagulants Additional treatment* -2 -1 • Symptomatic endometriosis Hysterectomy*2 -3 -1 • Prior uterine surgery (except low segment cesarean section) that interrupts the integrity of the uterine wall e.g., transmural Lost to follow-up* -2 -5 myomectomy or classical cesarean section Missed visit -1 -1 • Prior endometrial ablation Declined to participate* -1 0 • Patient on medications that could thin the myometrial muscle, such as Pregnancy* -1 0 long-term steroid use 24-Month 147 74 • Patient desire to have children or to preserve fertility follow-up data available • Patient currently on hormonal birth control therapy or unwilling to use a non-hormonal birth control post-ablation Additional treatment* 0 -4 • Abnormal/obstructed cavity as confirmed by hysteroscopy, SIS or HSG. Hysterectomy*2 -5 -1 Specifically: Lost to follow-up* -4 -2 - septate or bicornuate uterus or other congenital malformation of the 36-Month follow-up 138 67 uterine cavity Subject lost to follow-up at +1 +1 - pedunculated, submucous leiomyomata or other leiomyomata which 24 mos., returned at 36 mos. distort the cavity; polyps (larger than 2 cm) which are likely to be the cause of the patient’s menorrhagia 36-Month follow-up data 139 68 available - presence of an IUD * Discontinued patients • Suspected or confirmed uterine malignancy within the last five years 1 Four NovaSure did not meet protocol Inclusion Criteria; Two Rollerball had uterine perforation as confirmed by histology 2 For hysterectomy, see Table 7 • Endometrial hyperplasia as confirmed by histology Results • Unaddressed cervical dysplasia Primary effectiveness endpoint: bleeding score • Elevated FSH levels consistent with ovarian failure >40 IU/ml Patient success at 12-months post-procedure is defined as a reduction • Pregnancy in diary score from >150 pre-operatively to <75 post-procedure. • Active sexually transmitted disease Amenorrhea is defined as a score of 0. Success at 24 and 36 months, Patient population: A total of 265 patients were enrolled in this study. based on telephone questionnaires, is defined as elimination of bleeding Patients were between the ages of 25 to 50 with 46% under the age or reduction to light or normal flow. Data presented in Table 3 (below) of 40 and 54% 40 years of age or older. There were no differences in represent the clinical results based on the total number of 265 patients demographic or gynecological history parameters between the treatment randomized (Intent-to-Treat group (ITT)) for the study. The worst-case groups, between the age groupings or among the nine investigational sites. scenario is presented whereby each of the discontinued patients

7 ENGLISH

(described in Table 2 for patient accountability) is counted as a “failure” Table 4. Effectiveness: Quality of Life (QOL) for calculating the values listed in the table. Wire Loop Resection Table 3. Effectiveness: Success Rates–Intent-To-Treat Patients NovaSure Plus Rollerball Percent of Patients Reporting Sometimes, Frequently Or Always Wire Loop Resection Have Difficulty Performing Work Or Other Activities Due to Menses NovaSure Plus Rollerball (n=175) (n=90) Pre-operatively 66.3% 65.5% Months post ablation 12* 24** 36** 12* 24** 36** 12 Months 9.9%* 8.6%* 24 Months 14.5%* 15.0%* Number of successful patients 136 143 134 67 68 63 36 Months 16.3%* 13.3%* Percent of Patients Reporting Sometimes, Frequently Or Always Study success rate 77.7% 81.7% 76.6% 74.4% 75.6% 70.0% Feel Anxious Due to Menses # of patients with Pre-operatively 74.7% 68.9% Amenorrhea 63 64 58 29 26 23 12 Months 23.6%* 18.5%* Amenorrhea rate 36.0% 36.6% 33.1% 32.2% 28.9% 25.6% 24 Months 24.2%* 19.2%* * Based on diary scores 36 Months 18.7%* 19.1%* ** Based on telephone questionnaires Percent of Patients Reporting Sometimes, Frequently Or Always Secondary effectiveness endpoint: quality of life Miss Social Activities Due to Menses Patient quality of life (QOL) was assessed by administering the quality of Pre-operatively 63.3% 62.2% life questionnaire (SF-12) and the menstrual impact questionnaire prior 12 Months 8.5%* 8.6%* to treatment and at 3, 6, 12, 24 and 36 months post-procedure. Table 4 24 Months 9.0%* 11.1%* shows the patient responses for both groups pre-operatively, where 36 Months 8.1%* 10.8%* appropriate, and at 12, 24 and 36 months post-procedure. # Not all patients completed questionnaire * Statistically significant difference from pre-operative response (Chi-Square; p < 0.05) & Statistically significant difference between NovaSure and Rollerball Groups Table 4. Effectiveness: Quality of Life (QOL) (Chi-Square; p = 0.02) Wire Loop Resection Safety endpoint NovaSure Plus Rollerball Adverse event information is described in the “Adverse Events” section of this manual. Number of Patients Responding to Quality of Life Questionaire# Pre-operatively 175 90 Secondary endpoint: procedure time 12 Months 154 82 Procedure time, a secondary endpoint, was determined for each patient 24 Months 143 73 by recording the time of device insertion and the time of device removal. 36 Months 139 67 The mean procedure time for the NovaSure patients was significantly Percent of Patients Satisified Or Very Satisified less than the procedure time for the rollerball group, (4.2 ± 3.5 minutes 12 Months 92.8% 93.9% and 24.2 ± 11.4 minutes, respectively). Mean time for application of RF 24 Months 93.9% 89.1% energy was 84.0 ± 25.0 seconds in a subset of monitored NovaSure 36 Months 96.3% 89.7% patients (Table 5). Percent of Patients Who Probably Or Definitely Would Recommend Table 5. Operative Procedure Time This Procedure 12 Months 96.7% 95.9% Wire Loop Resection NovaSure Plus Rollerball 24 Months 96.6% 94.5% Operative Parameters n=175 n=90 36 Months 97.8% 92.6% Number of treated patients* 171 88 Percent of Patients with Dysemenorrhea Pre-operatively 57.1% 55.6% Procedure time minutes (± SD) 4.2 ± 3.5** 24.2 ± 11.4** 12 Months 20.8%& 34.2%*,& (Device insertion to device removal) 24 Months 20.3%* 30.1%* # 36 Months 17.3%* 28.4%* Procedure time in seconds (±SD) 84.0 ± 25.0 ND Percent of Patients with PMS (Time of energy delivery) Pre-operatively 65.1% 66.7% * See Table 2 for patient accountability ** Statistically significant difference between treatment groups (Student’s t-test; p < 0.05) 12 Months 36.4%* 35.4%* # Not determined 24 Months 44.0%* 46.6%* 36 Months 34.5%* 41.2%*

8 ENGLISH Secondary endpoint: anesthesia regimen Patient Counseling Anesthesia was left to the discretion of each patient, clinical investigator As with any procedure, the physician needs to discuss risks, benefits and attending anesthesiologist. For the NovaSure patients, 27.0% and alternatives with the patient prior to performing endometrial (47/174) had the procedure performed under general anesthesia or ablation. Patient’s expectations should be set in a way that the patient epidural and 73.0% (127/174) under local and/or IV sedation. One understands that the aim of the treatment is the reduction in bleeding to patient did not have a reported anesthesia regimen in this group. In normal levels. the rollerball group, 82.2% (74/90) of the patients were treated under The disposable device is intended for use only in women who do general anesthesia or epidural and 17.8% (16/90) under local and/or IV not desire to bear children because the likelihood of pregnancy is sedation (Table 6). significantly decreased following the procedure. Patients of childbearing capacity should be cautioned of potential complications, which may Table 6. Anesthesia Regimen ensue if they should become pregnant. This counseling should include Wire Loop Resection the need for post-procedure contraception where indicated. This NovaSure Plus Rollerball procedure is not a sterilization procedure and subsequent pregnancies n=175* n=90 may be dangerous for the mother and fetus. General or epidural 27.0% 82.2% Vaginal discharge is typically experienced during the first few weeks Local and/or IV sedation 73.0% 17.8% following ablation and may last as long as a month. Generally, * One patient did not have a reported anesthesia regimen. the discharge is described as bloody during the first few days; serosanguineous by approximately one week; then profuse and watery Clinical observations thereafter. Any unusual or foul-smelling discharge should be reported to Hysterectomy the physician immediately. Other common post-procedural complications Fifteen women had a hysterectomy within the three years following the include cramping/pelvic pain, nausea and vomiting. ablation procedure. Table 7 lists the reasons for hysterectomy. Uterine perforation should be considered in the differential diagnosis of any post-operative patient complaining of acute abdominal pain, fever, Table 7. Hysterectomy shortness of breath, dizziness, hypotension or any other symptom that Wire Loop Resection may be associated with uterine perforation with or without damage NovaSure Plus Rollerball to the adjacent organs of the abdominal cavity. Patients should be Reason For Hysterectomy n=175 n=90 counseled that any such symptoms should be immediately reported to Adenocarcinoma diagnosed at 1 1 their physician. time of ablation procedure Fibroids 2 0 Pretreatment Preparation of Patient Pelvic abscess 1 1 The NovaSure impedance controlled endometrial ablation system Endometriosis 3 0 successfully treats a uterine cavity over a range of endometrium thickness. The lining of the uterus does not have to be thinned prior to Adenomyosis 4 0 the procedure, and the procedure may be performed during either the Hematometra 0 1 proliferative or the secretory phase of the cycle. Although the safety and Menorrhagia 0 1 effectiveness of the NovaSure system has not been fully-evaluated in TOTAL 11 (6.3%) 4 (4.4%) patients with medical or surgical pretreatment, it has been evaluated in a 7 Hysterectomies were in patients <40 years (7 NovaSure) and 8 hysterectomies were in patients >40 years limited number of patients who had been pretreated with GnRH agonists (4 NovaSure; 4 Rollerball). with no complications or adverse events.

Patient Selection Active bleeding was not found to be a limiting factor when using Menorrhagia can be caused by a variety of underlying problems, the NovaSure system. It is recommended that a nonsteroidal anti- including, but not limited to; endometrial cancer, myomas, polyps, drugs inflammatory drug (NSAID) be given at least one hour prior to treatment and dysfunctional uterine bleeding (anovulatory bleeding). Patients and continued postoperatively to reduce intraoperative and postoperative always should be screened and evaluated to determine the cause of uterine cramping. excessive uterine bleeding before any treatment option is initiated. Consult medical literature relative to various endometrial ablation techniques, indications, contraindications, complications and hazards prior to the performance of any endometrial ablation procedure.

9 ENGLISH NovaSure Impedance Controlled Endometrial Ablation System 1.2 Prepare the NovaSure RF controller. Place it on a small table to one Instructions For Use side of the patient within visual field of the surgeon. Attach the AC Please read all instructions, cautions and warnings prior to use. power cord to the controller and plug it into the AC outlet.

1.3 Screw the CO2 canister into the regulator on the back panel of the 1.0 Set-up controller until tightened. Toggle switch

AC CO2 canister power cord

NOVASURE DISPOSABLE DEVICE WITH CONNECTING CORD, 1.4 Fully rotate the CO2 regulator knob to the HI position (if equipped). NOVASURE INCLUDING SUCTION LINE NOTE: Newer model controllers are not equipped with a knob on the RF CONTROLLER DESICCANT regulator, thus allowing the CO2 flow to be automatically regulated. If your controller is not equipped with a regulator knob, proceed to step 1.5. 1.5 Press the toggle switch on the back panel of the controller into the “on” position. NOVASURE POWER CORD NOVASURE SUCTION LINE 1.6 Connect the foot switch to the appropriate port on the front panel of the controller.

Port NOVASURE CO2 CANISTER NOVASURE FOOT SWITCH

1.1 The following items are required when using the NovaSure system: • one sterile, single-patient use NovaSure disposable device with connecting cord • one NovaSure RF controller • one NovaSure foot switch • one NovaSure AC power cord NOTE: The first time the Model 10 RFC is turned on, the “Select Your • one NovaSure non-sterile suction line desiccant assembly Language” screen will display. The default setting is in English. • one NovaSure CO canister. To select another language, press the button with the name 2 of that language. Save the selection by pressing the flashing Cavity Length Setting Lock Release green button. Button Vacuum Relief Valve The language selection will be retained. To change the language WIDTH Dial Cervical Collar selection after the initial setup, use the “Settings” screen. Press the name of the language to change the language used on the screen display. To save changes to the settings, press the flashing green Suction button. To cancel a selection, press the Blue “X”. Line Vacuum Sheath Feedback 2.0 Procedure Line Barb Rear Bipolar 2.1 Prepare the patient for the anesthesia. Handle Front Handle Electrode 2.2 Place patient in dorsal lithotomy position. Array 2.3 Induce anesthesia according to standard practice. 2.4 Perform bimanual examination. Evaluate for severe anteversion or NOTE: Please have available at least one extra disposable device, retroversion. desiccant assembly and CO2 canister.

10 ENGLISH 2.5 Prepare and drape patient similar to prep for D&C. 2.11 Open the sterile NovaSure disposable device package. Place the 2.6 Insert a speculum into the vagina. disposable device with the connecting cord into the sterile field 2.7 Grasp the cervix with a tenaculum. while being careful to keep the non-sterile suction line desiccant 2.8 Take a sound measurement of the uterus to measure the length box out of the sterile field. from fundus to external cervical os. The efficacy of the NovaSure WARNING: Do not use the sterile single-patient use disposable system has not been fully evaluated in patients with a uterine device if the packaging appears to be damaged or there is evidence sound measurement greater than 10 cm. of tampering. 2.9 Determine the length of the cervical canal and dilate the canal for device insertion. NOTE: The diameter of the NovaSure disposable device is a nominal 6 mm. 2.10 Using the uterine sound and cervical canal measurements, consult the cavity length table (below) to obtain the appropriate cavity length settings. On the upper end of the table, dimensions have been adjusted to reflect the disposable device electrode length. Correct determination of the cavity length is important for safe and effective treatment. Overestimating the cavity length may result in 2.12 Open the non-sterile suction line desiccant box and pouch. thermal injury to the endocervical canal. Remove the red caps. WARNING: Use caution not to perforate the uterine wall when sounding, dilating or inserting the disposable device.

TABLE 8. CAVITY LENGTH

Uterine Sound (cm) CAUTION: The suction line desiccant is non-sterile and the Cervix packaging should not be placed in the sterile field. Length CAUTION: If the suction line desiccant is pink, then replace it prior (cm) 10 9.5 9 8.5 8 7.5 7 6.5 6 to initiating the ablation procedure. 2 6.5* 6.5* 6.5* 6.5 6 5.5 5 4.5 4 2.13 Connect the desiccant to the barbs on the suction tubing of 2.5 6.5* 6.5* 6.5 6 5.5 5 4.5 4 disposable device. Ensure the barbs are fully inserted into the 3 6.5* 6.5 6 5.5 5 4.5 4 tubing on the desiccant. 3.5 6.5 6 5.5 5 4.5 4 4 6 5.5 5 4.5 4 4.5 5.5 5 4.5 4 5 5 4.5 4 5.5 4.5 4 6 4 * The value of 6.5 is not intended to reflect the numerical difference between the sound length and the length of the cervical canal. 2.14 CAUTION: Disposable device must be external to (outside of) The value 6.5 was entered because it represents the maximum length that the NovaSure the patient before performing step 2.15. array can be extended. 2.15 Connect the disposable device cord to the appropriate port on the CONTRAINDICATION: Do not treat a patient with a uterine cavity front panel of the controller. length that is less than 4 cm, as cervical canal damage may occur. NOTE: Patients with a uterine cavity length greater than 6.0 cm had observed success rates that were lower than overall study success rates.

Disposable Device Port

11 ENGLISH WARNING: Plugging the NovaSure disposable device into the

NovaSure RF controller starts CO2 flow to purge any air out of the disposable device and tubing. The purging operation takes approximately 10 seconds and must be performed with the disposable device external to the patient. The NovaSure RF controller CAVITY ASSESSMENT LED flashes red (Model 08-09 Lock release RFCs) or a purging device message displays (Model 10 RFC) and an button ARRAY audible pulsed tone sounds throughout the purge procedure. When CLOSED the tone and the LED/screen message stop, it is safe to insert the indicator NovaSure disposable device.

CAUTION: CO2 continuously flows from the time that the disposable 2.19 Make sure the array is completely enclosed by the external sheath. device is plugged into the controller until the CIA portion of the 2.20 Check that the WIDTH dial reads approximately 0.5 cm. procedure is complete. To minimize the duration of CO2 flow 2.21 Using the uterine sound measurement and cervical canal and potential risk of embolism, perform the seating procedure measurements, consult the cavity length table (above) to obtain the immediately after inserting the disposable device and proceed appropriate cavity length settings as described in step 2.10 above. directly from the seating procedure to the CIA. CONTRAINDICATION: Do not treat a patient with a uterine cavity WARNING: Use caution not to perforate the uterine wall when length that is less than 4 cm, as cervical canal damage may occur. sounding, dilating or inserting the disposable device. 2.22 Using the cavity length table in section 2.10, select the value 2.16 Deploy the disposable device outside of the patient and ensure the obtained for length into the NovaSure RF controller input screen by controller ARRAY POSITION LED is extinguished (Model 08-09 RFCs) depressing the UP/DOWN arrows. or the screen message does not display (Model 10 RFC) when the 2.23 Adjust and lock the cavity length setting feature on the disposable array is opened. If the LED is not extinguished (Model 08-09 RFCs) device to the value obtained above. (See step 2.21.) Ensure that the or the screen message is still displayed (Model 10 RFC), close cervical collar is fully retracted to its proximal position. and open the disposable device again. If this does not resolve the problem, replace the disposable device. 2.17 Be certain the WIDTH dial reads greater than or equal to 4.0 cm.

WIDTH dial

2.24 Confirm that the cervix is dilated to a minimum 6 mm (the nominal diameter of the NovaSure disposable device). 2.25 Maintain a slight traction on the tenaculum to minimize the angle of NOTE: If the WIDTH dial reads less than 4.0 cm, close the disposable the uterus. device and repeat step 2.16 above. If the WIDTH dial still reads 2.26 Angle the disposable device in-line with the axis of the uterus as less than 4.0 cm, open a new disposable device and return the old the disposable device is inserted transcervically into the uterine disposable device to Hologic Technical Support. cavity. By holding the front handle, advance the disposable device 2.18 Unlock the disposable device by pressing the lock release button. until the distal end of the sheath touches the fundus. Close the disposable device by holding the front handle stationary and gently pulling the rear handle backwards until the closed array indicator, located at the hinge of the front and rear handles, reads, “ARRAY CLOSED”. This indicates that the array has been retracted into the sheath and the disposable device is in the closed position.

12 ENGLISH 2.28 Continue to slowly squeeze the disposable device handles together while gently moving the disposable device ~0.5 cm to and from the fundus and rotating the handle of the disposable device 45° counterclockwise from the vertical plane and 45° clockwise from the vertical plane until the handles lock. The WIDTH dial should read greater than 2.5 cm.

NOTE: Once the disposable device handles are locked, the uterus should move in conjunction with the disposable device.

#10

2.29 Gently move the disposable device using anterior, posterior and lateral movements. WARNING: If the disposable device is difficult to insert into the cervical canal, use clinical judgment to determine whether or not further dilation is required. 2.27 Withdraw the disposable device approximately 0.5 cm from the fundus. Slowly squeeze the handles (DO NOT LOCK) up to the point of increased resistance. The WIDTH dial should read approximately 0.5 cm. At this point, the external sheath has been retracted. 0.5 cm 2.30 To complete placement, slightly pull back the disposable device until the WIDTH dial reading reduces by approximately 0.2–0.5 cm.

13 ENGLISH 2.31 Hold the tenaculum, advance the disposable device slowly and 2.33 Read the cornu-to-cornu measurement (2.5 cm minimum) on the gently to the fundus. The WIDTH dial should read greater than or WIDTH dial indicator. equal to the previous measurement. 2.32 Slide the cervical collar forward using gentle pressure on the tab on the cervical collar, until the cervical collar forms a seal against the external cervical os.

CONTRAINDICATION: Do not treat a patient with a uterine cavity width less than 2.5 cm, as determined by the WIDTH dial of the Gentle pressure disposable device following device deployment. CAUTION: If the ARRAY POSITION notification appears, see the Troubleshooting section under “ARRAY POSITION Alarm.” 2.34 Select the value indicated on the WIDTH dial into the NovaSure RF controller input screen by depressing the UP/DOWN arrows. Slight pressure 2.35 The system can be operated in either automatic mode or manual mode. In automatic mode the ablation cycle will start automatically upon successful completion of the cavity integrity assessment (CIA). In manual mode the ablation cycle will not start automatically following a successful CIA.

NOTE: Correct placement of the electrode array against the fundus is important to safe and effective treatment. If part of the electrode array or the distal edge of the external sheath is seated in the endocervical canal during treatment, there is an increased risk of endocervical thermal injury.

INCORRECT PLACEMENT CORRECT PLACEMENT Fundus Fundus

Electrode Array Electrode Array

Sheath Edge Endocervical Sheath Edge Endocervical Canal Canal

Sheath edge resides in Sheath edge resides in endocervical canal lower uterine segment

14 ENGLISH MODEL 08-09 RF CONTROLLERS MODEL 10 RF CONTROLLER

Follow next steps on pages 16 through 19. Follow next steps on pages 20 through 23.

Table of Contents for both Models 08-09 and Model 10 RF Controllers

Additional Troubleshooting ��24 Replacement Instructions ��24 Specifications ��25 Cleaning and Sanitizing ��28 Parts List ��28 Warranty ��29 Technical Support and Product Return Information ��29 Symbol Definitions. ��30

15 ENGLISH Model 08-09 RFC USERS ONLY Operating the Model 08-09 RF Controllers cervical collar, use another tenaculum to grasp the cervix around the sheath. Repeat the CIA by pressing the foot switch.

NOTE: CO2 leakage may occur at the external cervical os due to the presence of an over-dilated cervix. Visible bubbles or the “hissing”

sound of escaping gas may accompany CO2 leakage under either of these conditions. C. If the cavity integrity assessment fails after reasonable attempts to implement the troubleshooting procedures (step 2.36), abort the procedure. NOTE: Removing the disposable device from the uterine cavity after completing a cavity integrity assessment will require an additional CIA test to be performed upon disposable device re-insertion (whether or not the CIA previously passed) prior to initiating an A. Automatic mode ablation. To operate the system in automatic mode, press the ENABLE 2.37 Manual mode only button prior to beginning the Cavity Integrity Assessment (CIA). Proceed to step 2.36, but do not follow step 2.37 if operating the When operating the system in manual mode, the ablation cycle system in automatic mode. will not start automatically after the successful completion of the CIA. Once a successful CIA has been completed, press the ENABLE B. Manual mode button and depress the foot switch a second time to initiate the To operate the system in the manual mode, do not press the ablation cycle. ENABLE button prior to beginning the Cavity Integrity Assessment NOTE: In some Model 09 RF controllers, a vacuum pre-check (CIA). Follow steps 2.36 and 2.37. occurs automatically prior to initiation of the ablation cycle. The 2.36 Begin the CIA procedure by stepping on the foot switch once. VACUUM LED will flash and an audible tone will be heard for up to The CAVITY ASSESSMENT LED flashes green in conjunction with 10 seconds during the vacuum pre-check. an audible tone at a rate of once per second when the system is performing a CIA. The duration of the test will range between approximately 7 and 30 seconds. A steady green LED appears when the CIA has passed and the system can deliver RF energy. Power cannot be applied to the disposable device until the CAVITY ASSESSMENT LED is a steady green light. If the cavity integrity assessment fails, then the CAVITY ASSESSMENT LED on the NovaSure RF controller will flash red, and a rapid audible tone will sound at a rate of four times per second. MANUAL MODE

During the ablation cycle, a blue RF ON LED will illuminate. At the completion of the ablation cycle, the RF power delivery (RF ON LED), as well as suction, will switch off automatically. The physician can stop the progress of the procedure at any time by depressing the foot switch. NOTE: RF power delivery can be stopped at any time by pressing If the cavity integrity assessment fails, press the foot switch to stop the the foot switch sound. Next: 2.38 After automatic termination of the ablation cycle (approximately A. If a perforation is suspected, the procedure should be terminated 90 seconds), fully retract the cervical collar by using the tab on immediately. the cervical collar. Fully retract the cervical collar by sliding it to its B. If the CIA test fails again, check for leaks in the system, and between proximal position. the cervix and cervical collar. Be sure to check all tubing connections, and ensure that a suction line desiccant has been installed. If the leak appears to be at the cervix and cannot be resolved by using the

16 ENGLISH CAUTION: The cervical collar must be fully retracted to its proximal biohazardous waste and disposed of according to standard Model 08-09 RFC USERS ONLY position in order to minimize the potential for damage to the sheath practices of the hospital or clinic where the treatment is when closing the array. performed. Cervical 2.43 Discharge the patient from the hospital or office as indicated Collar by the managing physician. Periodic Maintenance and Service There is no service manual for the NovaSure RF controller since there are no field serviceable components within the unit. WARNING: No modification of this equipment is allowed. Periodic maintenance The RF controller has been designed and tested to meet IEC 60601-1 and other safety standards. Maintenance is not required 2.39 Unlock the disposable device by pressing the lock release button. as the system performs self-checks when power is turned on. To Close the disposable device by holding the front handle stationary clean the controller refer to the “Cleaning and Sanitizing” section. and gently pulling the rear handle backwards until the closed array indicator, located at the hinge of the front and rear handles, reads RF power output test “ARRAY CLOSED”. This indicates that the array has been retracted The NovaSure RF controller Model 08-09 integrates automatic into the sheath and the disposable device is in the closed position. power output testing into a power on self test (POST). During the (See step 2.18.) POST the controller’s power output (Pc) is delivered into a shunt NOTE: If it is difficult to close and remove the disposable device, resistor (Rs) located inside the controller. Pc is targeted to be 180 see the Troubleshooting section, “Difficulty closing and removing watts and Rs is nominally 25 ohms. During the POST, no power the disposable device post-ablation.” is delivered to the disposable device connector at the front of the controller. CAUTION: To avoid damaging the device, employ gentle technique when retracting the array. NOTE: If a NovaSure disposable device is connected at the time the controller is powered up, the POST will not be performed and the controller will return to normal operation. If a device is connected during the POST sequence, the POST will terminate and the controller will return to normal operation. The following procedure is used to execute the POST and display the actual value of Pc and Rs determined: 1. With the switch on the power input module in the off position, check to make sure a disposable device is not connected to the RF controller. 2. Depress and hold the length UP and length DOWN arrows 2.40 Withdraw the disposable device from the patient. simultaneously, then toggle the power switch at the power input module while continuing to depress the arrows. This step initiates the POST, which proceeds automatically. 3. Upon the completion of the POST (approximately 5 seconds), the RF controller will generate one audible tone, and then display the actual value of Pc for two seconds on the power set LED. 4. After two seconds elapse, the power set LED will change to display the actual value of Rs for two seconds. 5. The power set LED will then change to 00, and the RF controller will return to normal operation without further input from the user. The acceptable limits on Pc = 180 W ± 10%. If Pc is not within 2.41 Turn off the NovaSure RF controller. Close the CO regulator. specification, a system fault will occur. The actual value of Rs is for 2 reference only. 2.42 Perform postoperative patient care according to standard procedures. The used disposable device must be treated as

17 ENGLISH Model 08-09 RFC USERS ONLY NOTE: If a system fault occurs during the POST, toggle off the 1. Flashes red accompanied by an audible tone while the system is power at the power input module and repeat the POST. If a stabilizing the vacuum level for up to 10 seconds before energy system fault occurs a second time, remove the RF controller delivery commences (only for Model 09 controllers with a vacuum from service and contact Hologic customer service. pre-check function). CAUTION: Do not attempt to repair the controller if problems 2. Illuminates red when the vacuum relief valve is stuck in the closed are suspected. Follow the troubleshooting guide in this position, when a blockage is detected in the disposable device or the manual. If problems persist, call Hologic Technical Support connection tubing or when the system has a leak. Such a situation for instructions. might be created by: • an over-dilated cervix with poor contact between the cervical collar Sterile NovaSure disposable device: No maintenance is necessary. and the external os; Single-patient use only. Do not reuse or re-sterilize the NovaSure disposable device. • a poor attachment of the desiccant tube to the suction tubing; • an obstruction in the disposable device tubing; or

NovaSure RF Controller LED Descriptions • an obstruction in the disposable device. The following is a description of the alert LEDs on the SYSTEM FAULT LED: illuminates red if the system faults or if there is a NovaSure RF controller. self-diagnostic check failure with the system clock or power delivery. If CAVITY ASSESSMENT LED: illuminates in four modes: this event occurs, terminate the procedure immediately and contact an authorized Hologic service representative for instructions. 1. Flashes red in conjunction with an audible tone at a rate of once per second for the first 10 seconds when the system is Troubleshooting Most Common Alarms purging air out of the disposable device. After 10 seconds, the LED CAVITY ASSESSMENT LED illuminated red and audible tone will cease, although CO will continue to flow out 2 If the CAVITY ASSESSMENT LED is steady red, the cavity integrity of the vacuum feedback line. assessment has failed. If the cavity integrity assessment fails, then the 2. Flashes green in conjunction with an audible tone at a rate of CAVITY ASSESSMENT LED on the NovaSure RF controller will flash red, once per second when the system is performing a cavity integrity and a rapid audible tone will sound at a rate of four times per second. assessment. The CIA test may be tried again. 3. Steady green light appears when the cavity integrity assessment has passed and the system can deliver RF energy. If a perforation is suspected, the procedure should be terminated Power cannot be applied to the disposable device until the CAVITY immediately. ASSESSMENT LED is a steady green. If the cavity integrity assessment fails, press the foot switch to stop the 4. Steady red lights and an audible tone at a rate of four times sound. The cause of the cavity integrity assessment failure is the inability per second occur when the cavity integrity assessment has failed. to pressurize the cavity. It may be caused by: The CIA test may be tried again. 1. Device leak: ensure that the suction line desiccant filter has been ENABLE LED: illuminates amber when the user presses the installed. Check all tubing connections to ensure that they are tightly ENABLE button. Acts as a safety so that the NovaSure disposable connected. device will not accidentally activate when the foot switch is 2. Leak at the external os of the cervix: Look for visible bubbles or a touched. The ENABLE LED will not illuminate when the ARRAY “hissing” sound at the external os of the cervix. POSITION LED is on. Use the tab on the cervical collar to advance the cervical collar RF ON LED: illuminates blue when the ablation is proceeding towards the external os of the cervix to ensure there is a tight seal. (the foot switch has been depressed to activate the Test again. If the test fails again, use a second tenaculum to grasp NovaSure RF controller with the NovaSure disposable device array the cervix around the sheath of the NovaSure disposable device. Test in place in the uterus). again. PROCEDURE COMPLETE LED: illuminates when the tissue impedance 3. Uterine perforation: If a uterine perforation is suspected, the reaches 50 ohms and the ablation procedure runs a minimum of procedure should be terminated immediately.

30 seconds. NOTE: CO2 leakage may occur at the external cervical os due to the presence of an over-dilated cervix. Visible bubbles or the “hissing” ARRAY POSITION LED: illuminates red when one pole of the electrode sound of escaping gas may accompany CO leakage under either of array may be in contact with another. This LED should be illuminated 2 these conditions. when the array is not fully deployed. The ENABLE LED cannot be toggled on, nor can power be delivered to the array when the ARRAY POSITION LED is illuminated. VACUUM LED: illuminates in two conditions:

18 ENGLISH Model 08-09 RFC USERS ONLY

If the cavity integrity assessment fails after reasonable attempts to CO2 canister low or empty implement the troubleshooting procedures (step 2.36), abort the The NovaSure RF controller will generate an audible tone at a rate procedure. of four times per second during this alarm condition. LEDs that NOTE: Removing the disposable device from the uterine cavity after were illuminated prior to the alarm will remain in the same state during the low CO event. Pressing the foot switch will not turn off completing a cavity integrity assessment will require an additional 2 CIA test to be performed upon disposable device re-insertion the audible alarm.

(whether or not the CIA previously passed) prior to initiating an 1. Replace the CO2 canister to stop the audible tone. ablation. NOTE: It is not necessary to remove the disposable device VACUUM LED illuminated from the patient prior to replacing the canister. The VACUUM LED illuminates when the vacuum level is outside its 2. Continue with the procedure. specified range. This can occur as a result of one or more of the following: ARRAY POSITION LED illuminated 1. Gently move the proximal end of the disposable device and • an over-dilated cervix; observe if the ARRAY POSITION LED extinguishes. If it does not, • poor contact between the cervical collar and the external cervical os; proceed with the following: • the vacuum relief valve is in the closed position; 2. Attempt gentle reseating of the NovaSure disposable device: • an obstruction in the disposable device filter(s) (two) or desiccant; or A. Partially retract the array into the sheath by releasing the • an obstruction within the disposable device. disposable device handle lock release button; To eliminate this condition, perform the following: B. Pull the disposable device back slightly from fundus; C. Slowly redeploy the disposable device array while gently • Gently press a 2–3.5 mm uterine dilator or sound inside the vacuum rocking the disposable device back and forth and locking relief valve. the disposable device handles; and • Check the cervical collar position, and reposition it if necessary. Use D. Reseat the disposable device against fundus using the the tab on the cervical collar to advance the cervical collar towards the seating procedure described in steps 2.26 through 2.33. external os of the cervix to ensure there is a tight seal. Verify that air is 3. If the uterus is retroverted, take special care to avoid not being drawn through the cervix by a loose fit between the cervical perforation. Apply gentle caudad traction to the cervix with the collar and the entrance to the cervical canal. If air is being drawn in tenaculum, and elevate the disposable device handle upward through the cervical canal, try to reposition the cervical collar and toward the ceiling (in-line with the axis of the uterus) while disposable device shaft to prevent air ingress. performing the seating procedure. • Ensure the suction canister on the disposable device is vertical and the 4. If the ARRAY POSITION LED is still illuminated, fully retract the device tubing is not draped over the patient’s leg. disposable device array and remove the disposable device • Check all tubing connections to ensure that they are tightly connected. from the patient. Check the push-on tubing connectors at the desiccant tube. Replace 5. Deploy the disposable device outside the patient’s body; ensure the the dessicant if it is pink. Ensure that the filter located near the electrode array is undamaged and that the ARRAY POSITION LED disposable connection on the vacuum feedback line is tightened. extinguishes. • Reattempt ablation. 6. Attempt reinsertion, redeployment and reseating of the disposable If the VACUUM LED illuminates again: device using the seating procedure described in section 2.0. • Disconnect the disposable device from the RF controller. 7. If the ARRAY POSITION LED remains illuminated, replace with a new disposable device. • Remove the disposable device from the patient, then; 8. If the ARRAY POSITION LED remains illuminated with a new • Exchange the disposable device with a new disposable device. disposable device, terminate the procedure. • Reattempt the ablation with the new device. If a vacuum alarm occurs with the new device, abort the procedure: NOTE: Removing the disposable device from the uterine cavity after Please turn to page 24 for the remainder of completing a cavity integrity assessment will require an additional the Instructions for Use. CIA test to be performed upon disposable device re-insertion (whether or not the CIA previously passed) prior to initiating an ablation.

19 ENGLISH Model 10 RFC USERS ONLY Operating the Model 10 RF Controller C. If the cavity integrity assessment fails after reasonable attempts to implement the troubleshooting procedures (step 2.36), abort the procedure. NOTE: Removing the disposable device from the uterine cavity after completing a cavity integrity assessment will require an additional CIA test to be performed upon disposable device re-insertion (whether or not the CIA previously passed) prior to initiating an ablation. 2.37 Manual Mode Only When operating the system in manual mode, the ablation cycle will not start automatically after the successfully completion of the cavity integrity assessment (CIA). Once a successful CIA has been completed, press the ENABLE button and depress the foot switch a second time to initiate the ablation cycle. NOTE: In all Model 10 RF controllers, a vacuum pre-check occurs automatically prior to initiation of the ablation cycle. A “Vacuum Check in Progress” screen will appear and an audible tone will be A. Automatic mode heard for up to 10 seconds during the vacuum pre-check. To operate the Model 10 RFC in Automatic Mode, press the During the ablation cycle, an “RF ON” screen with a timer will “Switch Mode” button when it appears at the bottom of the appear to track the duration of the ablation. screen. Proceed to step 2.36, but do not follow step 2.37 if operating the system in automatic mode. B. Manual mode NOTE: Manual Mode is the default system operation. To operate the system in manual mode, do not press the “Switch Mode” button prior to beginning the cavity integrity assessment (CIA). Follow steps 2.36 and 2.37. NOTE: RF power delivery can be stopped at any time by pressing 2.36 Begin the CIA procedure by stepping on the foot switch once. the foot switch. “Cavity Assessment in Progress” will display on the screen while 2.38 After automatic termination of the ablation cycle (approximately 90 five dots light off and on sequentially. The duration of the test seconds), fully retract the cervical collar to its proximal position by will range between approximately 7 and 30 seconds. A “Cavity using the tab on the cervical collar. Assessment Complete” screen displays when the CIA has passed CAUTION: The cervical collar must be fully retracted to its proximal and the system can deliver RF energy. Power cannot be applied to position in order to minimize the potential for damage to the sheath the disposable device until the CIA Complete screen displays. when closing the array. If the cavity integrity assessment fails, a screen will display Cervical “Cavity Assessment Failure” with troubleshooting steps. Collar A. If a perforation is suspected, the procedure should be terminated immediately. B. If the CIA test fails again, check for leaks in the system, and between the cervix and cervical collar. Be sure to check all tubing connections, and ensure that a suction line desiccant has been installed. If the leak appears to be at the cervix and cannot be resolved by using the cervical collar, use another tenaculum to grasp the cervix around the sheath. Repeat the CIA test by pressing the foot switch.

NOTE: CO2 leakage may occur at the external cervical os due to the presence of an over-dilated cervix. Visible bubbles or the “hissing” sound of escaping gas may accompany CO2 leakage under either of these conditions.

20 ENGLISH At the completion of the ablation cycle, a “Procedure Complete” screen Periodic maintenance Model 10 RFC USERS ONLY will appear with a summary of the procedure. The “Procedure Complete” The RF controller has been designed and tested to meet IEC screen will capture the following information for each procedure: 60601-1 and other safety standards. Maintenance is not required • Cavity Length as the system performs self-checks when power is turned on.To • Cavity Width clean the controller refer to the “Cleaning and Sanitizing” section. • Power Level RF power output test • RF Ablation Time The NovaSure RF controller Model 10 integrates automatic power output testing in a power on self test (POST). During the POST the controller’s power output (Pc) is delivered into a shunt resistor (Rs) located inside the controller. Pc is targeted to be 180 watts and Rs is nominally 25 ohms. During the POST, no power is delivered to the disposable device connector at the front of the controller. The NovaSure RF controller Model 10 performs POST automatically upon power up. To access POST information, go to 2.39 Unlock the disposable device by pressing the lock release button. Settings and scroll to System Information. Press the “View Info.” Close the disposable device by holding the front handle stationary button. and gently pulling the rear handle backwards until the closed array NOTE: If a system fault occurs during the POST, toggle off the indicator, located at the hinge of the front and rear handles, reads power at the power input module and repeat the POST. If a “ARRAY CLOSED”. This indicates that the array has been retracted system fault occurs a second time, remove the RF controller into the sheath and the disposable device is in the closed position. from service and contact Hologic customer service. NOTE: If it is difficult to close and remove the disposable device, CAUTION: Do not attempt to repair the controller if problems see the Troubleshooting section, “Difficulty closing and removing are suspected. Follow the troubleshooting guide in this the disposable device post-ablation”. manual. If problems persist, call Hologic Technical Support for CAUTION: To avoid damaging the device, employ gentle technique instructions. when retracting the array. Sterile NovaSure disposable device: No maintenance is necessary. 2.40 Withdraw the disposable device from the patient. Single-patient use only. Do not reuse or re-sterilize the NovaSure disposable device.

NovaSure Model 10 RF Controller Screen Icons The following is a description of the icons on the NovaSure Model 10 RF controller screen. Last Procedure Icon: Settings Icon: Press this button to display the Press this button to display the “Procedure Complete” Screen setting options for Language, and review the summary from Brightness, and Volume. the last procedure.

2.41 TURN OFF THE NOVASURE RF CONTROLLER. 2.42 Perform postoperative patient care according to standard procedures. The used disposable device must be treated as biohazardous waste and disposed of according to standard practices of the hospital or clinic where the treatment is performed. 2.43 Discharge the patient from the hospital or office as indicated by the managing physician. Periodic Maintenance and Service Help Icon: Press this button to display more information There is no service manual for the NovaSure RF Controller since there regarding the current step of the procedure. are no field serviceable components within the unit. This icon will display an abridged version of the IFU language. WARNING: No modification of this equipment is allowed.

21 ENGLISH Model 10 RFC USERS ONLY NOTE: When the “Last Procedure” Icon is pressed, only NOTE: CO2 leakage may occur at the external cervical os due to the the previous procedure will be displayed. Information for presence of an over-dilated cervix. Visible bubbles or the “hissing” procedures prior to the most recent procedure will not be sound of escaping gas may accompany CO2 leakage under either of available. these conditions. NOTE: In the “Settings” screen, press the “-” or “+” buttons NOTE: When following the troubleshooting steps on the Model 10 to adjust the volume and brightness. RFC, press the “?” button on the screen and use the scroll buttons on the right for more information. To get back to the main screen from the additional troubleshooting tips, press the “X” in the top right corner of the screen. If the cavity integrity assessment fails after reasonable attempts to implement the troubleshooting procedure (step 2.36), abort the procedure.

VACUUM ALARM The Vacuum alarm occurs when the vacuum level is outside its specified range. This can occur as a result of one or more of the following: NOTE: The first time the Model 10 RFC is turned on, the • An over-dilated cervix; “Select Your Language” screen will display. The default • Poor contact between the cervical collar and the external cervical os; setting is in English. To select another language, press the button with the name of that language. Save the selection by • The vacuum relief valve is in the closed position; pressing the flashing green button. The language selection • An obstruction in the disposable device filter(s) (two) or desiccant; or will be retained. To change the language selection after the • An obstruction within the disposable device. initial setup, use the “Setting” screen. Press the name of the If the Vacuum check fails, a screen will display “Vacuum Failure” with an language to change the language used on the screen display. abridged version of the following troubleshooting tips: To save changes to the settings, press the flashing green • Gently press a 2-3.5 mm uterine dilator or sound inside the vacuum button. To cancel a selection, press the blue “X”. relief valve Troubleshooting Most Common Alarms • Check the cervical collar position, and reposition if necessary. Use the tab on the cervical collar to advance the cervical collar towards the CAVITY ASSESSMENT ALARM external os of the cervix to ensure there is a tight seal. Verify that air is If the cavity integrity assessment fails, a screen will display not being drawn through the cervix by a loose fit between the cervical “Cavity Assessment Failure” with an abridged version of the collar and the entrance to the cervical canal. If air is being drawn in troubleshooting tips below. The cause of the cavity integrity through the cervical canal, try to reposition the cervical collar and assessment (CIA) failure is the inability to pressurize the cavity. It disposable device shaft to prevent air ingress. may be caused by: • Ensure the suction canister on the disposable device is vertical and the 1. Device leak: Ensure that the suction line desiccant filter has been device tubing is not draped over the patient’s leg. installed. Check all tubing connections to ensure that they are tightly • Check all tubing connections to ensure that they are tightly connected. connected. Check the push-on tubing connectors at the desiccant tube. Replace 2. Leak at the external os of the cervix: Look for visible bubbles or a the desiccant if it is pink. Ensure that the filter located near the “hissing” sound at the external os of the cervix. disposable connection on the vacuum feedback line is tightened. Use the tab on the cervical collar to advance the cervical collar • Reattempt ablation. towards the external os of the cervix to ensure there is a tight seal. If the “Vacuum Failure” screen displays again: Perform the CIA test again. If the CIA test fails again, use a second • Disconnect the disposable device from the RF controller. tenaculum to grasp the cervix around the sheath of the NovaSure • Remove the disposable device and replace with a new disposable disposable device. Perform the CIA test again. device. 3. Uterine perforation: If a perforation is suspected, the procedure • Reattempt the ablation with the new device. should be terminated immediately.

22 ENGLISH NOTE: When following the troubleshooting steps on the Model 10 4. If the Array Position message still displays, fully retract the Model 10 RFC USERS ONLY RFC, press the “?” button on the screen and use the scroll buttons disposable device array and remove the disposable device on the right for more information. To get back to the main screen from the patient. from the additional troubleshooting tips, press the “X” in the top 5. Deploy the disposable device outside the patient’s body; right corner of the screen. ensure the electrode array is undamaged and that the Array If the vacuum alarm occurs with the new device, abort the procedure. Position message no longer displays. 6. Attempt reinsertion, redeployment and reseating of the NOTE: Removing the disposable device from the uterine cavity after disposable device using the seating procedure described in completing a cavity integrity assesment will require an additional section 2.0. CIA test to be performed upon disposable device re-insertion 7. If the Array Position message still displays, replace with a new (whether or not the CIA previously passed) prior to initiating an disposable device. ablation. 8. If the Array Position message displays with a new disposable

CO2 canister low or empty device, terminate the procedure.

A screen will display “Replace CO2” with an image of the back of the NOTE: When following the troubleshooting steps on the Model controller. An audible tone will be generated at a rate of 1 time per 10 RFC, press the “?” button on the screen and use the scroll second. Alarm messages that were present prior to the alarm will remain buttons on the right for more information. To get back to the in the same state during the replace CO2 event. Pressing the foot switch main screen from the additional troubleshooting tips, press will not turn off the audible alarm. the “X” in the top right corner of the screen.

1. Replace the CO2 canister to stop the audible tone. NOTE: It is not necessary to remove the disposable device from the patient prior to replacing the canister. 2. Continue with the procedure. ARRAY POSITION Alarm The Array Position message displays when the array is not open fully. The controller cannot perform ablation when Array Position message Please turn to next page 24 for the displays. If the ARRAY POSITION alarm occurs, a screen will display remainder of the Instructions for Use. “Check Array” with an abridged version of the following troubleshooting tips: 1. Gently move the proximal end of the disposable device and observe if the Array Position message no longer displays. If it still displays, proceed with the following: 2. Attempt gentle reseating of the NovaSure disposable device: A. Partially retract the array into the sheath by releasing the disposable device handle lock release button; B. Pull the disposable device back slightly from the fundus; C. Slowly redeploy the disposable device array while gently rocking the disposable device back and forth and locking the disposable device handles; and D. Reseat the disposable device against the fundus using the seating procedure described in steps 2.26 through 2.33. 3. If the uterus is retroverted, take special care to avoid perforation. Apply gentle caudad traction to the cervix with the tenaculum, and elevate the disposable device handle upward toward the ceiling (in-line with the axis of the uterus) while performing the seating procedure.

23 ENGLISH INSTRUCTIONS FOR USE ALL USERS INSTRUCTIONS Additional Troubleshooting PROCEDURE COMPLETE LED not illuminated (Model 08-09 RFCs) or “Procedure Complete” Screen does not appear (Model 10 Suspected uterine perforation RFC) at the end of a procedure Prior to Application of Energy: During or after Application of 1. If power has not been applied for at least 30 seconds, the LED will Energy: not illuminate (Model 08-09 RFCs) or the “Procedure Complete” 1. Terminate the procedure 1. Terminate the procedure Screen will not appear (Model 10 RFC). Remove the NovaSure disposable device from the uterus after fully retracting the disposable 2. Assure patient stability 2. Assure patient stability device array into the sheath: 3. Consider work-up for 3. Rule out visceral injury A. Release the disposable device lock release button; perforation 4. Reschedule procedure, B. Hold the disposable device front handle steady; and 4. Reschedule procedure, if appropriate C. Pull the disposable device rear handle backward. if appropriate 2. Inspect the disposable device for any damage. Fully deploy the Array does not fully deploy and lock in uterus electrode array outside the patient, demonstrating that the ARRAY 1. Partially retract array into sheath (hold the front handle POSITION LED does not illuminate (Model 08-09 RFCs) or that the stationary and pull the rear handle back and away from the message does not display (Model 10 RFCs). patient); 3. If the disposable device is not damaged and the ARRAY POSITION 2. Reposition the disposable device in the cavity; LED extinguishes (Model 08-09 RFCs) or the message screen 3. Redeploy the array in cavity; does not appear (Model 10 RFC), reinsert, redeploy and reattempt treatment. 4. If the disposable device does not lock, remove it from the uterus; 4. If the problem persists, replace the disposable device with a new disposable device. 5. Inspect the disposable device for damage; 5. Reattempt the procedure. If the problem persists, terminate the 6. Attempt to open the disposable device and lock it outside the procedure. patient; 7. If damaged, the replace disposable device; RF ON LED will not illuminate (Model 08-09 RFCs) or the “RF 8. If the disposable device is not damaged, reinsert it into the ON” screen will not appear (Model 10 RFC) patient’s uterine cavity and attempt deployment; and 1. If the NovaSure RF controller is plugged in, switched on, the ENABLE 9. If unable to deploy the disposable device to a minimum 2.5 cm button has been pressed and no power is delivered from the cornu-to-cornu distance, terminate the procedure. controller when the foot switch is depressed, check the foot switch 10. Consider uterine perforation as a possible cause for not connection. Also make sure the CAVITY ASSESSMENT has passed. deploying. 2. If the problem persists, terminate the procedure. Difficulty closing and removing the disposable device UP/DOWN values will not appear when pressing the appropriate post-ablation buttons Confirm that the lock release button is depressed: Make sure that the disposable device is connected to the controller. The values will not appear unless the disposable device is properly • If so, gradually withdraw the disposable device from the connected to the controller. patient. • If not, press the lock release button and reattempt to close the Replacement Instructions disposable device. If it is still difficult to close, gradually withdraw The NovaSure RF controller uses a pair of fuses that are located on the disposable device from the patient. a fuse carrier in the power input module. Type T5AH, 250 V fuses are ENABLE LED will not illuminate (Model 08-09 RFCs only) used. The module can be accessed by using a slotted screwdriver to Be sure: pop open the fuse carrier door. If required, the fuse carrier may then be removed and the fuses changed. Assembly is the reverse of these steps. 1. The ENABLE button is firmly depressed; Any potentially defective NovaSure product must be returned to Hologic 2. The NovaSure RF controller is plugged in; for evaluation. Follow the instructions at the end of this manual in the 3. The toggle switch at the back of the controller is on; and Service Returns section, for obtaining a returned materials authorization 4. The ARRAY POSITION LED is not illuminated. number (RMA #). Do not discard the NovaSure disposable device.

NovaSure disposable device 1. The NovaSure disposable device does not contain latex.

24 ENGLISH INSTRUCTIONS FOR USE ALL USERS INSTRUCTIONS

2. The NovaSure disposable device is a Class III device by FDA maximum flow rate of CO2 from the NovaSure RF controller regulation. connected to the disposable device shall be 95 ± 15 ml/

3. The NovaSure disposable device is a Class IIB device according to min. (The maximum flow rate of CO2 from the NovaSure RF the MDD 93/42/EEC. controller without a NovaSure disposable device attached is 4. The NovaSure disposable device tip nominal diameter: 6 mm. 117 ± 13 ml/ min.) 5. The NovaSure disposable device overall dimensions: 13. The Novasure RF Generator should be used without a neutral 19” x 6” x 12” (48.3 cm x 15.2 cm x 5 cm). electrode. 6. The NovaSure disposable device has a voltage rating of 153 V. Power vs. Resistance NovaSure RF controller 1. The NovaSure RF controller can be used with outlets providing 100 to 240 VAC and will draw a maximum of 5 Amps. 2. The NovaSure RF controller is a Class I, defibrillator-proof Type BF instrument, according to IEC 60601-1. 3. The NovaSure RF controller is a Class III device by FDA regulation. 4. The NovaSure RF controller is a Class IIB device according to the MDD 93/42/EEC. 5. The RF controller has been tested and found to comply with the Measured Power (Watts) limits for medical devices according to IEC 60601-1-2 ED 4.0: 2014. These limits are designed to provide reasonable protection against harmful interference in a typical medical installation. This equipment Load Resistance (Ohms) generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to other devices in the vicinity. However, there Actual Power vs. Power Setting into a 20 Ohm Load is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to other devices, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures: • Re-orient or relocate the receiving device • Increase the separation between equipment • Connect the equipment into an outlet on a circuit different from that to which the other device(s) is/are connected. Actual Power (Watts) • Contact Hologic Technical Support (or the manufacturer of the other equipment) for assistance. 6. The controller meets the requirements of IEC 60601-1/UL 60601-1, IEC 60601-2-2 and CSA C22.2 No.601.1. Power Setting (Ohms) 7. Shipment of the controller should be done only in the original Hologic Operating, non-packaged conditions packaging. Environmental requirements for use, shipping and storage are indicated below. Altitude 0 to 10,000 ft (0 to 3,030 m) 8. The absolute maximum peak voltage generated by the Temperature 10° C to 40° C (50° F to 104° F) NovaSure RF controller is 153 volts. Accessories used with the RF Humidity 15 to 85% RH at 40° C (non-condensing) controller should have a voltage rating equal to or greater than 153 volts. 9. The absolute maximum peak power generated by the Non-operating, packaged conditions NovaSure RF controller is 216 watts. Altitude 0 to 40,000 ft (0 to12,120 m) 10. NovaSure RF controller weight: 24 lbs (11 kg), unpacked. Temperature –30° C to 60° C (–22° F to 140° F) 11. Height: 12.5”; Width: 7.5”; Depth: 14.5” Humidity 85% RH, 72 hr, at 38° C (non-condensing) (32 cm x 19 cm x 35.5 cm).

12. The maximum pressure of CO2 delivered from the NovaSure RF controller and disposable device shall be 90 ± 10 mmHg.The

25 ENGLISH INSTRUCTIONS FOR USE ALL USERS INSTRUCTIONS Electromagnetic emissions Essential Performance: Emissions Compliance Electromagnetic Environment – • Air must be purged from the device for 10 seconds prior to Test Guidance insertion in patient. RF Group 1 The NovaSure RF controller must emit • The Cavity Integrity Assessment (CIA) must measure a pressure Emissions electromagnetic energy in order to of 50 ± 10 mm of Hg for 3 seconds minimum to pass. Otherwise CISPR 11 perform its intended function. Nearby the CIA will report an error. The RF controller will not enable an electronic equipment may be affected. ablation to begin until CIA passes. RF Class A The NovaSure RF controller is intended Emissions for use in Professional Healthcare • RF power: The range of RF power delivery is 55 to 180 (+/-20%) CISPR 11 Facilities including hospitals and watts. physician’s offices. • Vacuum pressure monitoring: During an ablation the vacuum Harmonic Class A emissions WARNING: The EMISSIONS pressure must be in the range of 0.7 ±0.2 in Hg to 6 ±1.0 in Hg. characteristics of this equipment If the vacuum pressure exceeds this range, the controller will end IEC make it suitable for use in industrial the ablation. 61000-3-2 areas and hospitals (CISPR 11 Class Voltage Complies A). If it is used in a residential • Impedance monitoring: The RF Controller will end an ablation environment (for which CISPR 11 when the measured tissue impedance reaches 50 ohms. The fluctuations/ flicker Class B is normally required) this controller also will act the same if the impedance is measured as emissions equipment might not offer adequate less than 0.5 ohms. IEC protection to radio-frequency • Two minute timer: After two minutes of RF energy delivery, the 61000-3-3 communication services. The user might need to take mitigation controller will end the ablation measures, such as relocating or re- • Ten minute timeout: after completing the ablation procedure the orienting the equipment. controller times out for 10 minutes, during which the controller is incapable of delivering energy. WARNING: In some circumstances, the potential exists for alternate • DC Short Circuit protection: If the RF controller detects a short site burns whenever a high-frequency device is used. Skin-to-skin circuit (i.e. <13+/-6ohms), the ablation will be ended. contact should be avoided, for example, by insertion of dry gauze. WARNING: With any electrosurgical device, the potential for arcing Guidance and manufacturer’s declaration – exists, and neuromuscular stimulation may occur.When this device electromagnetic emissions and immunity is used properly in the uterus, the risk of muscle stimulation, The NovaSure RF controller is intended for use in the particularly heart muscle, is remote. electromagnetic environment specified below. The customer ELECTROMAGNETIC IMMUNITY or user of the NovaSure RF controller should ensure that it is used in such an environment. Immunity IEC 60601 Compliance Electromagnetic Test Test Level Level Environment – Guidance Electrostatic ±2kV, ±2kV, ±4kV, Floors should be wood, discharge ±4kV, ±8kV ±8kV Contact concrete or ceramic (ESD) Contact tile. If floors are covered with synthetic material, IEC 61000- ±2kV, ±4kV, ±2kV, ±4kV, 4-2 the relative humidity ±8kV, ±15kV ±8kV,±15kV should be at least 30%. Air Air

26 ENGLISH INSTRUCTIONS FOR USE ALL USERS INSTRUCTIONS Immunity IEC 60601 Compliance Electromagnetic Immunity IEC 60601 Compliance Electromagnetic Test Test Level Level Environment – Test Test Level Level Environment – Guidance Guidance Electrical ±0.5kV, ±1kV, ±0.5kV, ±1kV, Mains power quality Portable and mobile RF fast ±2 kV for ± 2kV for should be that of a communications equipment transient/ power supply power supply typical commercial or should be used no closer to burst lines lines hospital environment. any part of the RF generator, including cables, than the IEC 61000- recommended separation 4-4 100kHz 100kHz distance calculated from the repetition repetition equation applicable to the frequency frequency frequency of the transmitter. Surge ±0.5kV, ±0.5kV, Mains power quality IEC 61000- ±1 kV line(s) ±1 kV line(s) should be that of a Recommended 4-5 to line(s) to line(s) typical commercial or separation distance hospital environment. Conducted 3 V 3 V 150 kHz to ±0.5kV, ±1kV, ±0.5kV, ±1kV, RF 0.15 MHz - 80 0.15 MHz - 80 80 MHz ±2 kV line(s) ±2 kV line(s) IEC MHz MHz to earth to earth 61000-4-6 6 V in ISM and 6 V in ISM and Voltage 0 % UT ; 0.5 0 % UT ; 0.5 Mains power quality amateur radio amateur radio dips, short cycle At 0°, cycle At 0°, should be that of a bands between bands between interuptions, 45°, 90°, 45°, 90°, typical commercial or 0.15 MHz and 0.15 MHz and and voltage 135°, 180°, 135°, 180°, hospital environment. 80 MHz 80 MHz variations 225°, 270° 225°, 270° If the user of the 80% AM at 1 kHz 80% AM at 1 kHz on power and 315° and 315° NovaSure RF controller supply input requires continued lines operation during power Radiated RF 3 V/m 3 V/m 80 MHz to mains interruptions, it is 800 MHz recommended that the IEC 80 MHz - 80 MHz - 0 % UT; 1 0 % UT; 1 61000-4-3 IEC 61000- cycle and cycle and NovaSure RF controller 2.7GHz 2.7GHz 800 MHz to 4-11 be powered from an 80% AM at 80% AM at 2.7 GHz 70 % U ; 70 % U ; uninterruptible power 25/30 cycles 25/30 cycles 1 kHz 1 kHz where P is the maximum supply or battery. output power rating Single phase: Single phase: of the transmitter in at 0° at 0° watts (W) and d is the recommended separation distance in meters (m). Field strengths from 0 % UT ; 250 0 % UT ; 250 fixed RF transmitters, cycles cycles as determined by an electromagnetic site survey,a should be less than the compliance level This condition in each frequency range.b causes the RF controller Interference may to shut occur in the vicinity of down and equipment marked with then return the following symbol: to standby mode. Power 30 A/m 30 A/m Power frequency Frequency 50 Hz 50 Hz magnetic fields should 50/60Hz be that of a typical commercial or hospital Magnetic environment. Field IEC 61000-4-8

27 ENGLISH INSTRUCTIONS FOR USE ALL USERS INSTRUCTIONS NOTE 1: At 80 MHz and 800 MHz, the higher frequency range immerse unit in liquid or introduce liquid into the cooling vents or RF applies. cable areas. NOTE 2: These guidelines may not apply in all situations. The NovaSure disposable device is a sterile disposable device for single- Electromagnetic propagation is affected by absorption and patient use only. reflection from structures, objects and people. • Do not use if the packaging is opened or damaged. a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast • Do not reuse or re-sterilize the disposable device. cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured Do not sterilize any component of the NovaSure impedance controlled field strength in the location in which the RF generator is used exceeds the applicable RF endometrial ablation system. compliance level above, the RF generator should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the RF generator. Parts List b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m. Ordering information and related parts and accessories

Recommended separation distances between portable Product Number Description and mobile RF communications equipment and the RFC2009 NovaSure RF Controller, Model 09 NovaSure RF controller The NovaSure RF controller is intended for use in the RFC2010 NovaSure RF Controller, Model 10 electromagnetic environment in which radiated RF disturbances 814002 Power Cord, 115 Volts, North America are controlled. The customer or the user of the NovaSure RF 814003 Power Cord, 230 Volts, Europe controller can help prevent electromagnetic interference by 814004 Power Cord, 220 Volts, United Kingdom/Ireland maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the NovaSure RF 814005 Power Cord, Denmark controller as recommended in the following table, according to the 814009 Power Cord, Italy maximum output power of the communications device. 814011 Power Cord, Switzerland Recommended separation distance 814015 Power Cord, Japan 814016 Power Cord, Australia Rated Separation distance according to frequency of maximum transmitter RFC2000-FS Foot Switch output power of m 815012 CO2 (USP), Cylinder 5 Pack transmitter 150 kHz to 80 MHz to 800 MHz to 2.7 GHz W NS2013 NovaSure Impedance Controlled Endometrial 80 MHz 800 MHz Ablation Disposable Device Kit NS2013KIT NovaSure Kit: 3 NovaSure Impedance Controlled 0.01 0.12 0.12 0.23 Endometrial Ablation Disposable Devices packaged 0.1 0.37 0.37 0.74 with 3 SureSound devices 1 1.2 1.2 2.3 300001 Biohazard Kit 10 3.7 3.7 7.4 100 12 12 23 Warranty

For transmitters rated at a maximum output power not listed above, the recommended separation Except as otherwise expressly stated in the Agreement: i) Equipment distance d in meters (m) can be estimated using the equation applicable to the frequency of the manufactured by Hologic is warranted to the original Customer transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. to perform substantially in accordance with published product NOTE 1: At 80 MHz and 800 MHz, the separation distance for the specifications for one (1) year starting from the date of shipment, or if higher frequency range applies. Installation is required, from the date of Installation (“Warranty Period”); NOTE 2: These guidelines may not apply in all situations. ii) digital imaging mammography x-ray tubes are warranted for twenty- Electromagnetic propagation is affected by absorption and four (24) months, during which the x-ray tubes are fully warranted for the reflection from structures, objects and people. first twelve (12) months and are warranted on a straight-line prorated Cleaning and Sanitizing basis during months 13-24; iii) replacement parts and remanufactured The use of nonflammable agents for cleaning and sanitizing is items are warranted for the remainder of the Warranty Period or ninety recommended. Flammable agents or solvents for cleaning or sanitizing (90) days from shipment, whichever is longer; iv) consumable Supplies should be allowed to evaporate before use of the NovaSure system. are warranted to conform to published specifications for a period ending on the expiration date shown on their respective packages; The NovaSure RF controller is not sterile. Cleaning should be done using v) licensed Software is warranted to operate in accordance with a mild detergent and water solution to wipe surface areas only. Do not published specifications; vi) Services are warranted to be supplied in

28 ENGLISH INSTRUCTIONS FOR USE ALL USERS INSTRUCTIONS a workman-like manner; vii) non-Hologic Manufactured Equipment is Hologic Ltd. warranted through its manufacturer and such manufacturer’s warranties Heron House Oaks BusinessPark, Crewe Road, shall extend to Hologic’s customers, to the extent permitted by the Wythenshawe, Manchester, M23 9HZ, UK manufacturer of such non-Hologic Manufactured Equipment. Hologic Phone: +44 (0)161 946 2206 does not warrant that use of Products will be uninterrupted or error-free, or that Products will operate with non-Hologic authorized third-party Federal law (USA) restricts this device to sale by or on the order of products. a physician with appropriate training. These warranties do not apply to any item that is: (a) repaired, moved, or Service returns altered other than by Hologic authorized service personnel; (b) subjected Read these instructions prior to returning any used/unused to physical (including thermal or electrical) abuse, stress, or misuse; potentially defective product to Hologic. (c) stored, maintained, or operated in any manner inconsistent with Contact Hologic Technical Support if the NovaSure disposable applicable Hologic specifications or instructions, including Customer’s device or RF controller fails to operate as intended. If product is to refusal to allow Hologic recommended Software upgrades; or (d) be returned to Hologic for any reason, Technical Support will issue designated as supplied subject to a non-Hologic warranty or on a pre- a Returned Materials Authorization (RMA) number and biohazard release or “as-is” basis. kit if applicable. Technical Support and Product Return Information Return RF controllers according to the instructions provided by WARNING: Dropping the RF controller voids the warranty and could Technical Support. Be sure to clean the RF controller before damage the controller beyond repair. We strongly recommend a returning it and include all accessories in the box with the returned stable cart which includes strapping or stabilizing the controller unit. to reduce the risk of being dropped. Please use extra care if Return used or opened disposable devices according to the transporting the RF controller to an off-site facility. If you have any instructions provided with the Hologic-supplied biohazard kit. questions regarding the RF controller, please call 1-800-442-9892 Hologic and its distributors and customers in the European or (508) 263-2900. Community are required to comply with the Waste Electrical and Service representatives Electronic Equipment (WEEE) Directive (2002/96/EC). Hologic is Should the NovaSure RF controller become inoperable, contact Hologic dedicated to meeting country specific requirements related to Technical Support for instructions and a return materials authorization the environmentally sound treatment of its products. Hologic’s number (RMA #). Clean and repackage the controller appropriately and objective is to reduce the waste resulting from the disposal of its return it for repair or servicing to the authorized locations listed below. If electrical and electronic equipment. Hologic realizes the benefits the controller is not under warranty, an appropriate handling and repair of subjecting such WEEE to potential reuse, treatment, recycling charge will be established at receipt and examination of the NovaSure or recovery to minimize the amount of hazardous substances RF controller. entering the environment. Hologic customers in the European Community are responsible for ensuring that medical devices For More Information marked with the following symbol, indicating that the WEEE For Technical Support or reorder information in the United States, Directive applies, are not placed into a municipal waste system please contact: unless authorized to do so by local authorities. Hologic, Inc. 250 Campus Drive Marlborough, MA 01752 USA Phone: 800-442-9892 (toll-free) Contact Hologic Technical Support to arrange for proper disposal of the www.hologic.com RF controller in accordance with the WEEE Directive. NOTE: Any disposable device-related incident or problem, which is believed to represent a safety issue, should be reported to Hologic Technical Support. International customers, contact your distributor or local Hologic Sales Representative:

29 ENGLISH Symbol Definitions Protect from heat Alternating current (AC) Radio frequency (RF) energy (non-ionizing radiation) Atmospheric pressure limitation Serial number Batch code Sterilized using ethylene oxide

Carbon dioxide CO2 Sterilized by irradiation

Catalog number Temperature limitation

Category non-AP equipment This side up

CE marking of conformity Use by with notified body identification number 0086 Contains or presence of phthalate Dangerous voltage Hologic, SureSound, NovaSure and associated logos are trademarks and/ Date of manufacture or registered trademarks of Hologic, Inc. and/or its subsidiaries in the United States and/or other countries. Defibrillator-proof Type BF equipment The NovaSure impedance controlled endometrial ablation system is manufactured and distributed by Hologic, Inc. Do not resterilize © 2014-2018 Hologic, Inc. Do not re-use

Do not stack above “n” high

Do not use if package is damaged

Equipotential ground

European Community Waste Electrical and Electronic Equipment (WEEE) Directive 2002/96/EC

Foot switch

Follow instructions for use

Fragile

Fuse

High pressure HP

Humidity limitation

Keep dry

Manufacturer

No oil

Not made with natural rubber latex

30 ENGLISH

AW-09898-000 Rev. 012

31 ENGLISH